Study of KRAS-Specific Vaccine in Patients With KRAS-Mutated Solid Tumors

Prior treatment

• (2)Patients received proteasome inhibitors and immunomodulators, radiotherapy, or approved Chinese traditional medicine within 2 weeks or 5 half-lives prior to the first vaccination(whichever is shorter), (3) patients with meningeal, brainstem, or spinal cord metastases and/or compression, or active central nervous system (CNS) metastases; Participants with asymptomatic brain metastases within 4 weeks before the first vaccination and who do not require steroid treatment for at least 14 days are eligible for enrolment.
• (4) patients with active second primary malignancy; however, patients received curative treatment and without known active disease for ≥2 years or non-melanoma skin cancer patients who received adequately treatment and with no evidence of disease will be eligible for study entry (5) patients with severe uncontrolled infection (bacterial, viral, fungal, etc.) during the screening period; (6) known positive test results for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA titer above the normal range or positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA titer above the normal range or positive for human immunodeficiency virus (HIV) antibody; positive syphilis test within 6 months prior to the vaccinations.
• Myocardial infarction or coronary artery bypass graft (CABG) or coronary stent implantation within ≤6 months prior to signing the ICF;
• Stroke or seizure within 6 months prior to screening;

Other illness

• (7)Patients with symptomatic heart failure or other cardiac diseases such as severe arrhythmias:
• New York Heart Association (NYHA) Class III or IV congestive heart failure;
• Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding vasovagal or dehydration-related causes);
• History of severe non-ischemic cardiomyopathy; （8）patients with other diseases, including:
• Significant clinical evidence of dementia or altered mental status;
• Parkinson's disease or Parkinson-like movement disorders or history thereof;

Lab values

• Uncontrolled hypothyroidism or hyperthyroidism; (9)Surgery within 2 weeks prior to the vaccination or planned surgery within 2 weeks after the vaccination, excluding local anesthesia; （10）Uncontrolled hypertension, hypercalcemia, or diabetes; （11）Vaccination with live attenuated vaccines within 1 month prior to the first infusion; （12） Patients who have undergone long-term systemic corticosteroid therapy; （13）Known severe allergic reactions to eDC products or their formulation components (e.g., albumin, IL-2) （14）eDC-KRAS preparation failed; （15）Researchers believe that other reasons are not suitable for clinical trials

Other

• Primary immunodeficiency;

• (8) Participants must have measurable lesions detected by computed tomography (CT) or magnetic resonance imaging (MRI) (according to iRECIST criteria);
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